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This is a phase 1 single center clinical trial for patients with end stage Metastatic Castration Resistant Prostate Cancer who have progressed through standard of care treatment options and are on zoledronate for bone metastases. This clinical trial includes a dose-escalation phase and dose-expansion phase to assess the safety and preliminary efficacy of treatment with autologous T cells genetically modified to express Prostate stem cell antigen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. The lymphodepletion regimen includes cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) administered over 3 days (Days -5, -4, -3). The standard "3+3" design will be used to guide dose escalation/de-escalation decisions based on the cumulative number of patients who experience a dose limiting toxicity (DLT) at the current dose. The first cohort of 3 patients will be treated at dose level 1. The target maximum doses infused at each dose level is: Dose Level 1: 1x10^5 cells/kg Dose Level 2: 3x10^5 cells/kg Dose Level 3: 1x10^6 cells/kg Dose Level 4: 3x10^6 cells/kg Dose Level 5: 1x10^6 cells/kg |
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| Dose Expansion | Experimental | Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive MSGV1-PSCA-8T28Z at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSGV1-PSCA-8T28Z | Biological | Autologous Gamma Delta T Cells Genetically Engineered with a Chimeric Receptor to Target the Prostate Stem Cell Antigen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z | MTD of MSGV1-PSCA-8T28Z based on Dose Limiting Toxicity (DLT) in patients with Metastatic Castration-Resistant Prostate Cancer. | Up to 30 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Best Prostate Specific Antigen (PSA) Response rate | Best PSA Response rate, which will be measured by percentage of patients who had 50% decline in PSA. | Up to 5 years |
| Radiographic progression-free survival (rPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gillian Zankel | Contact | 813-745-0876 | ICETtrials@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Jingsong Zhang, MD, PhD | Moffitt Cancer Center | Principal Investigator |
| Daniel Abate-Daga, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Fludarabine | Drug | Fludarabine is an antimetabolite given prior to lymphodepletion. |
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| Cyclophosphamide | Drug | Cyclophosphamide is a nitrogen mustard-derivative, polyfunctional alkylating agent given prior to lymphodepletion. |
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rPFS is defined as the duration of time from start of treatment to time of progression or death.
| Up to 5 years |
| Percentage of circulating tumor cell count conversion from above 5/ml to below 5/ml. | The Circulating tumor cell conversion rate from above 5 to less than 5 will be used as a response criteria. | Up to 5 years |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |